A Study Of Poly (ADP-Ribose) Polymerase Inhibitor PF-01367338 In Combination With Several Chemotherapeutic Regimens

A Parallel Arms Phase 1 Safety, Pharmacokinetic And Pharmacodynamic Study Of The Intravenous Poly (ADP-Ribose) Polymerase (PARP) Inhibitor PF-01367338 (AG-014699) In Combination With Several Chemotherapeutic Regimens In Adult Patients With Advanced Solid Tumor

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01009190

Enrollment

Registered

2009-11-06

Start date

2010-02-28

Completion date

2014-04-30

Last updated

2023-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumors

Keywords

Dose finding PARPi Chemotherapy

Brief summary

Dose escalation phase 1 study of PARP inhibitor PF-01367338 in combination with chemotherapy in adult patients with advanced solid tumors

Interventions

DRUGPF-01367338

Increasing doses of single lead-in (Day -10) intravenous and daily oral PF-01367338 administered from Day 1 to Day 14 every 3-week cycle

DRUGCarboplatin

Standard doses of intravenous Carboplatin administered every 3 weeks

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with histologically confirmed solid tumors, Eastern Cooperative Oncology Group (ECOG) 0 or 1 * Patients with acceptable renal, hepatic, and bone marrow function

Exclusion criteria

* Symptomatic and/or unstable brain metastases, * Any cancer treatment within 4 weeks from study entry

Design outcomes

Primary

Measure	Time frame	Description
Safety and tolerability of escalating doses of PF-01367338 in combination with chemotherapy (as defined by first-cycle DLTs)	18 months	Dose-limiting toxicities and adverse events

Secondary

Measure	Time frame	Description
Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens	18 months	Time to attain maximum plasma concentration \[Tmax\]
PARP activity and expression in peripheral blood lymphocytes (PBL)	18 months	% PARP activity
Determination of food effect on oral PF-01367338 pharmacokinetics	18 month	fasted and fed parameters area under the plasma concentration-time curve from time 0 to the last recorded observation \[AUClast\]
Determination of effect of PF-013567338 administration on QTc prolongation test	18 months	electrocardiogram\[ecg\], QTcF, QTcB

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026